Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia
Status:
Terminated
Trial end date:
2018-09-23
Target enrollment:
Participant gender:
Summary
DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus
Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both
drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster
region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net
recommendations the study will be conducted in NCCCR (National Center for Cancer Care &
Research) sample size calculations detailed in the statistic part the clinical hematologist
will recruit the patients this will include consenting process inclusion and exclusion
criteria the molecular pathologist will do the molecular testing the clinical research
coordinator and fellows will do the CRF (Case Report Form) as well as quality of life
questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular
monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid
Leukemia).